Cardiac Trigger Monitor

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

Ivy Biomedical Systems, Inc.

The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Cardiac Trigger Monitor.

Pre-market Notification Details

Device IDK202138
510k NumberK202138
Device Name:Cardiac Trigger Monitor
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford,  CT  06405
ContactAlejandra Aceves
CorrespondentAlejandra Aceves
Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford,  CT  06405
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2021-05-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816396023222 K202138 000
00816396022874 K202138 000
00816396022881 K202138 000
00816396023079 K202138 000
00816396021495 K202138 000
00816396022898 K202138 000
00816396022904 K202138 000
00816396022928 K202138 000
00816396022935 K202138 000
00816396023062 K202138 000
00816396023086 K202138 000
00816396023208 K202138 000
00816396023215 K202138 000
00816396022867 K202138 000

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